Clinical trials: Shigellosis
Shigellosis
A Human Challenge Study to Assess Protection of a Shigella Tetravalent Bioconjugate Vaccine
In this challenge study, the bioconjugate candidate vaccine Shigella4V2 will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella sonnei strain…
- Trial name
- S4V03 (NCT06615375)
- Testing
- Shigella4V2
- Where
- 3 sites in United States
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Shigellosis
Study to Expand Safety and Immunogenicity Data With Shigella Bioconjugate Vaccine (Shigella4V2) in 9-month-old Infants.
In this study, the second-generation tetravalent bioconjugate candidate vaccine Shigella4V2 will be tested to confirm data on its safety and immunogenicity in infants and to identify the best dose of Shigella4V2 in 9-month-old…
- Trial name
- S4V02 (NCT06523231)
- Testing
- Shigella4V2, MenACWY
- Where
- Kenya
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Shigellosis
A Study to Determine If a New Shigella Vaccine is Safe, Induces Immunity and The Best Dose Among Kenyan Infants
In this study, the tetravalent bioconjugate candidate vaccine Shigella4V will be tested to obtain first-in-human data on its safety and immunogenicity in infants and to identify the preferred dose of Shigella4V in 9 month old…
- Trial name
- NCT04056117
- Testing
- Shigella 4V, MenACWY, Rabies
- Where
- 2 sites in Kenya
- Volunteers
- 597 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Shigellosis
Safety and Efficacy of the Bacteriophage Preparation, ShigActive™, in a Human Experimental Model of Shigellosis
The study is a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled trial to assess the clinical safety and efficacy of ShigActive in healthy adults with experimental Shigella challenge.
- Trial name
- NCT05182749
- Testing
- bacteriophage
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Intralytix, Inc.
Shigellosis
Shigella Sonnei 53G Human Infection Study in Kenyan Adults
Diarrhoea caused by Shigella (shigellosis) is of major public health importance. However, there are no licensed Shigella vaccines in routine use, with several candidates still in various stages of clinical development.
- Trial name
- NCT05959616
- Testing
- Shigella sonnei 53G, Ciprofloxacin 500 mg
- Where
- Kenya
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Shigellosis
Controlled Human Infection Model Challenge/Rechallenge
The goal of this study is to better understand Shigella immunity. The study will compare the shigellosis rate in participants previously challenged with a different Shigella serotype to the attack rate in participants not…
- Trial name
- NCT04992520
- Testing
- Shigella sonnei 53G, Shigella flexneri 2a 2457T
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- PATH
Shigellosis, Bacillary Dysentery
InvaplexAR-Detox and DmLT Adjuvant in the Netherlands and Zambia
The goal of this clinical trial is to test a new Shigella vaccine (InvaplexAR-DETOX) in combination with a new adjuvant (dmLT) in healthy participants.
- Trial name
- SUNSHINE (NCT05961059)
- Testing
- 2.5 μg InvaplexAR-Detox, 10 μg InvaplexAR-Detox, 0.1 μg of dmLT
- Where
- Netherlands
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Leiden University Medical Center
Dysentery, Shigellosis
Efficacy, Immunogenicity and Safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in Volunteers Aged From 6 Months to 5 Years
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine in infants and children aged from 6 months to 5 years.
- Trial name
- NCT05156528
- Testing
- S. Flexneriza-S. Sonnei Bivalent Conjugate Vaccine
- Where
- 9 sites in China
- Volunteers
- 21,000 people, healthy volunteers welcome
- Sponsor
- Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Shigellosis
Safety Study of Inactivated Shigella Whole Cell Vaccine in Adults
This is a research study about an experimental (investigational) oral inactivated whole cell Shigella flexneri 2a killed vaccine (Sf2aWC).
- Trial name
- NCT01509846
- Testing
- Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose, Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses, Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses
- Where
- 2 sites in United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- PATH
Shigellosis, Bacillary Dysentery
Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR)
This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2a InvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2a InvaplexAR vaccine doses.
- Trial name
- NCT02445963
- Testing
- Shigella flexneri 2a InvaplexAR
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Shigellosis
Phase 2b Challenge Study With the Bioconjugate Vaccine Flexyn2a
In this proof of concept challenge study, the bioconjugate candidate vaccine Flexyn2a will be tested for its ability to induce an immune response that protects healthy adult volunteers from infection with a wild-type Shigella…
- Trial name
- NCT02646371
- Testing
- Flexyn2a
- Where
- United States
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Immunogenicity, Shigellosis
Shigella Sonnel O-SPC/rBRU Conjugate Vaccine
The active ingredient of this Shigella sonnei O-SP-core conjugate vaccine is a saccharide-protein conjugate composed of a fragment of S. sonnei LPS.
- Trial name
- NCT01369927
- Testing
- Shigella Sonnei O-SPC/rBRU
- Where
- Israel
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Shigellosis
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route…
- Trial name
- NCT02017899
- Testing
- S. sonnei 1790GAHB
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
Shigellosis, Bacillary Dysentery
SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers
This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose escalation (two doses), placebo-controlled study in healthy volunteers.
- Trial name
- NCT02797236
- Testing
- SF2a-TT15 vaccine, SF2a-TT15 vaccine + adjuvant
- Where
- Israel
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
Shigellosis
Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the…
- Trial name
- NCT00485134
- Testing
- 240 µg Shigella flexneri 2a Invaplex 50 vaccine, 480 µg Shigella flexneri 2a Invaplex 50 vaccine, 690 Shigella flexneri 2a Invaplex 50 vaccine
- Where
- 2 sites in United States
- Volunteers
- 113 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Soil-transmitted Helminthiasis, Schistosomiasis
Diagnosis of Neglected Tropical Diseases Among Patients With Persistent Digestive Disorders
NIDIAG is an international collaboration on integrated diagnosis-treatment platforms, funded by the European Commission (EC). NIDIAG aims to develop an improved, patient-centred system for delivering primary health care in…
- Conditions
- Soil-transmitted Helminthiasis, Schistosomiasis, Strongyloidiasis, Shigellosis
- Trial name
- NIDIAGDigest (NCT02105714)
- Testing
- Stool culturing for pathogenic bacteria, Kato-Katz technique, Baermann technique
- Where
- 7 sites in Côte d’Ivoire, Indonesia and 2 more
- Volunteers
- 2,800 people, healthy volunteers welcome
- Sponsor
- Swiss Tropical & Public Health Institute
Shigellosis
Evaluate a New Shigella Sonnei Vaccine Administered Either by Intradermal, Intranasal or Intramuscular Route in Healthy Adults
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) when administered at different dosages by different routes…
- Trial name
- NCT02034500
- Testing
- S. sonnei 1790GAHB
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
Shigellosis
Safety and Tolerability of a Bioconjugate Vaccine Against Shigella Flexneri 2a
This is a phase I, single-blind, randomized, placebo-controlled, single-center study in healthy subjects using a staggered approach to dosing.
- Trial name
- NCT02388009
- Testing
- Flexyn2a, Flexyn2a plus adjuvant
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- LimmaTech Biologics AG
Shigellosis
Safety and Reactogenicity of Bioconjugate Vaccine to Prevent Shigella
Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity of the Shigella dysenteriae bioconjugate vaccine…
- Trial name
- NCT01069471
- Testing
- Shigella vaccine
- Where
- Switzerland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlycoVaxyn AG